Improving Adherence to Medication After Coronary Artery Bypass Surgery (CABG) in Older Adults

January 9, 2023 updated by: Amir H Pakpour, Qazvin University Of Medical Sciences
Coronary artery bypass grafting (CABG) surgery is often performed in elderly patients, but non-adherence to post-CABG guideline medications is a common and serious clinical concern in this age group. A recent systematic review found that higher medication adherence significantly improved primary and secondary prevention of coronary artery disease outcomes in all the included studies. Another systematic review assessed studies published from 1999-2009 about motivational interviews, such as implementation intention, in relation to cardiovascular health. They found that motivational interview was an effective means of changing behavior, while offering promise in improving cardiovascular health status. The study is aimed to investigate effectiveness of long term volitional intervention in proving medication adherence in the CABG patient.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Ahvaz, Iran, Islamic Republic of
        • Golestan
      • Ahvaz, Iran, Islamic Republic of
        • Mehr
      • Qazvin, Iran, Islamic Republic of, 3419759811
        • Booali Sina Hospital
      • Qazvin, Iran, Islamic Republic of
        • Velayat Hospital
      • Semnān, Iran, Islamic Republic of
        • Kosar
      • Tabriz, Iran, Islamic Republic of
        • Shahid Madani
      • Tehran, Iran, Islamic Republic of
        • Firoozgar
      • Tehran, Iran, Islamic Republic of
        • Imam Khomeini
      • Tehran, Iran, Islamic Republic of
        • Rajaie
      • Tehran, Iran, Islamic Republic of
        • Shariati
      • Tehran, Iran, Islamic Republic of
        • Tehran Heart Center
      • Zahedan, Iran, Islamic Republic of
        • Khatam
      • Zanjan, Iran, Islamic Republic of
        • Mousavi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 65 years or older
  • Undergoing Elective/subacute multivessel CABG
  • Able to give informed consent

Exclusion Criteria:

  • Pregnant
  • Already using Dosette boxes (or similar) to improve their medication adherence
  • Currently enrolled in another clinical trial
  • Unable to attend required follow-up visits
  • Mini Mental Status Examination (MMSE) less than 20
  • Significant dysphasia
  • Concomitant surgery
  • Myocardial infarction <48h of surgery
  • Known platelet disease
  • Allergic to aspirin
  • Alcohol or narcotics abuse
  • Geographically not available for follow up
  • Ongoing bleeding
  • Missing written consent
  • Emergency surgery
  • Severe kidney disease (creatinine clearance < 30 ml/min)
  • Oxygen-dependent chronic obstructive pulmonary disease
  • Active hepatitis
  • Significant hepatic failure
  • Prior peptic ulcer• Platelet count < 150 E9
  • Patient has terminal condition and may not survive until 6-month follow-up
  • Patient is a known participant in other RC studies
  • The inability to read and write Persian/Farsi
  • Participants who are not responsible for their own medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence
Behavioral: Motivational Interviewing (MI
Five weekly motivational and volitional session sessions and each last about 50 minutes. Five registered psychologists will moderated the session. All MI technique and planing intervention will be used.
Other Names:
  • facilitate behavior change
Behavioral: volitional intervention
Five weekly motivational and volitional session sessions and each last about 50 minutes. Five registered psychologists will moderated the session. All MI technique and planing intervention will be used.
Other Names:
  • Planning intervention
Active Comparator: Usual Care
The usual care group received routine discharge counseling performed by the cardiologists and nurses.
Behavioral: Routine discharge counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
changes in Patient-reported medication Adherence to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor)
Time Frame: changes from baseline , 6 Months, 12 months and 18 months after the intervention
changes from baseline , 6 Months, 12 months and 18 months after the intervention
Changes in Percent of Patients Adherent to four therapies (aspirin/antiplatelet; beta blocker; statin; ACE inhibitor) Via Refill Records
Time Frame: changes from baseline , 6 Months, 12 months and 18 months after the intervention
changes from baseline , 6 Months, 12 months and 18 months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in action planning
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
The number of planning strategies is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in coping planning
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
The number of planning strategies is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in quality of life
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Mortality rate and Myocardial Infarction
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Beliefs about Medications
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Illness Perceptions
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in habit strength
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Patient's habits on medications use before, at baseline, six months, twelve months and eighteen months after the intervention
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in total cholesterol
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in blood pressure
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in triglyceride
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in high-density lipoproteins-cholesterol
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Low-density lipoproteins-cholesterol
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qazvin University Of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amir H Pakpour, PhD, Qazvin University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 28/20/7200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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